[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07673120":3,"trial-entities:NCT07673120":108,"trial-summary:NCT07673120":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":50,"secondary_outcomes":70,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":84,"locations":86,"central_contacts":96,"overall_officials":102,"references":106,"see_also_links":107},"NCT07673120","M26-216","A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313","RECRUITING","2028-02","2026-07","2026-07-24","2026-06-24","AbbVie","INDUSTRY",false,"The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.",null,[19],"Healthy Volunteers",[19,21],"ABBV-313","INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE1",{"count":27,"type":28},64,"ESTIMATED",[30,39,42,48],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Injection",[34,35,36,37,38],"Part 1, Group 1: ABBV-313 or Placebo","Part 1, Group 2: ABBV-313 or Placebo","Part 1, Group 5: ABBV-313 or Placebo","Part 2, Group 7: ABBV-313 or Placebo","Part 2, Group 8: ABBV-313 or Placebo",{"type":31,"name":40,"description":32,"armGroupLabels":41},"Placebo",[34,35,36,37,38],{"type":31,"name":21,"description":43,"armGroupLabels":44},"Infusion",[45,46,47],"Part 1, Group 3: ABBV-313 or Placebo","Part 1, Group 4: ABBV-313 or Placebo","Part 1, Group 6: ABBV-313 or Placebo",{"type":31,"name":40,"description":43,"armGroupLabels":49},[45,46,47],[51,55,58,61,64,67],{"measure":52,"description":53,"timeFrame":54},"Number of Participants with Adverse Events (AEs)","An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.","Up to Approximately Day 329",{"measure":56,"description":57,"timeFrame":54},"Maximum Observed Plasma Concentration (Cmax) of ABBV-313","Cmax of ABBV-313.",{"measure":59,"description":60,"timeFrame":54},"Time to Cmax (Tmax) of ABBV-313","Tmax of ABBV-313.",{"measure":62,"description":63,"timeFrame":54},"Terminal Phase Elimination Rate Constant (Beta) of ABBV-313","Beta of ABBV-313.",{"measure":65,"description":66,"timeFrame":54},"Terminal Phase Elimination Half-Life (t1\u002F2) of ABBV-313","t1\u002F2 of ABBV-313.",{"measure":68,"description":69,"timeFrame":54},"Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313","AUCt of ABBV-313.",[],"ALL","18 Years","55 Years",true,{"inclusion":76,"exclusion":79,"raw_text":83},[77,78],"BMI is \\>= 18.0 to \\\u003C= 29.9 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.","A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.",[80,81,82],"History of any clinically significant sensitivity or allergy to any medication or food.","History of any clinically significant illness\u002Finfection\u002Fmajor febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.","Participant has prior exposure to ABBV-313 within the past 300 days.","Inclusion Criteria:\n\n* BMI is \\>= 18.0 to \\\u003C= 29.9 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* History of any clinically significant illness\u002Finfection\u002Fmajor febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.\n* Participant has prior exposure to ABBV-313 within the past 300 days.",[85],"ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Acpru \u002FId# 283495","Grayslake","Illinois","60030","United States",{"lat":94,"lon":95},42.34447,-88.04175,[97],{"name":98,"role":99,"phone":100,"email":101},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[103],{"name":104,"affiliation":13,"role":105},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[19],[],{"nct_id":4,"found":74,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This interventional study plans to enroll 64 healthy adult participants. Some will receive ABBV-313 and others will receive a placebo, either as an injection or an infusion.","completed","A Study of ABBV-313 in Healthy Adults","This study is looking for healthy adult volunteers to help us understand a new investigational drug called ABBV-313. We want to learn about its safety, how well your body tolerates it, and how your body processes it. Some participants will receive ABBV-313 as an injection or infusion, while others will receive a placebo (an inactive substance that looks like the study drug). We'll be checking for any side effects and measuring how much ABBV-313 is in your blood over time. You can join if you are between 18 and 55 years old, in good general health, and have a BMI (Body Mass Index) between 18.0 and 29.9. The study plans to enroll 64 participants, but its current recruitment status is unclear.","Participants will be followed for safety and drug levels for up to approximately 329 days.",121,"Not specified in the trial record.","Not stated in the trial record.",[21,40],"v2"]